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WO2007033638A1 - Automatic injection device for two-chamber ampullas - Google Patents

Automatic injection device for two-chamber ampullas Download PDF

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Publication number
WO2007033638A1
WO2007033638A1 PCT/DE2006/001512 DE2006001512W WO2007033638A1 WO 2007033638 A1 WO2007033638 A1 WO 2007033638A1 DE 2006001512 W DE2006001512 W DE 2006001512W WO 2007033638 A1 WO2007033638 A1 WO 2007033638A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection
stroke
injection device
receptacle
chamber
Prior art date
Application number
PCT/DE2006/001512
Other languages
German (de)
French (fr)
Inventor
Wilfried Weber
Original Assignee
Bayer Schering Pharma Aktiengesellschaft
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Schering Pharma Aktiengesellschaft filed Critical Bayer Schering Pharma Aktiengesellschaft
Priority to US12/067,766 priority Critical patent/US7678072B2/en
Priority to CN2006800342676A priority patent/CN101267856B/en
Priority to JP2008531522A priority patent/JP5076109B2/en
Priority to DE112006003252T priority patent/DE112006003252A5/en
Priority to CA2623152A priority patent/CA2623152C/en
Priority to EP06791326.9A priority patent/EP1931405B1/en
Priority to BRPI0616307-6A priority patent/BRPI0616307B1/en
Priority to MX2008002782A priority patent/MX2008002782A/en
Priority to KR1020087006734A priority patent/KR101309718B1/en
Publication of WO2007033638A1 publication Critical patent/WO2007033638A1/en
Priority to HK08113242.1A priority patent/HK1119098A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31555—Mechanically operated dose setting member by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3156—Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31563—Mechanically operated dose setting member interacting with a displaceable stop member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • the patient For the treatment of a variety of diseases that have become very widespread, such as diabetes, the patient must self-inject the required amount of an agent / drug by means of a syringe or a carpule.
  • injection devices which include a largely automatic process of piercing the needle, injecting the drug and retrieving the needle.
  • the two active ingredients are usually housed in a syringe body with two chambers, which are separated from each other and between which a connection is made shortly before the injection, then the two active ingredients (if possible, for the patient - Bar trackable).
  • injection devices are known, with the aid of a sequence of mixing, puncturing and injecting is made possible (DE 600 11 853 T2).
  • the control of these processes is done manually and thus requires for handling great attention on the part of the patient, especially since no retrieval of the needle is provided after shot injection.
  • An administration device for a multi-chamber ampoule is shown in DE 103 40 585 A1.
  • the manual effort for injection is similar, two cylindrical, coaxially associated with each other housing halves in which the ampoule is inserted, are manually pressed or mixed for mixing until an end position is reached; Thereafter, the injection is to be performed by an injection mechanism 1 , which is not shown in detail.
  • An automated retrieval of the needle is not provided here.
  • Another object is to individually regulate the relatively critical for two-component drugs dosages for the individual patient and the associated penetration depths at the puncture site, so that an optimization for each patient both in terms of the injected drug volume, as well as the penetration depth of the needle can be achieved.
  • the injection device according to the invention solves this problem with the features of patent claim 1.
  • the basic idea of the invention is to bring about the succession of the hoop exclusively by means of a simple drive mechanism, a cable pull.
  • the stroke performed by the plunger by acting on the two-chamber ampoule is divided into a preliminary mixing stroke and an injection stroke, which are interrupted by the Einstechhub. This ensures that the needle is not pierced into the puncture site until the two active ingredients have been mixed and, if appropriate, assessed by the patient through a window as correct.
  • Preferred embodiments relate to the design of the setting elements for sequence control, which are also designed for independent adjustment of the piercing depth and the adjustment of the injection volume of the mixed active substance.
  • FIG. 1A a side view of the injection device in the starting position
  • FIG. 1C shows a section through the injection device in the plane SS of FIG. 1B
  • FIG. FIG. 2A shows a side view of the injection device during the execution of the mixing stroke
  • FIG. 2B a sectional view corresponding to FIG. 2A
  • FIG. 3A shows a side view of the injection device during the insertion stroke
  • FIG. 3B a sectional view according to FIG. 3A
  • FIG. 4A a side view of the injection device during the injection stroke
  • FIG. 4B a sectional view according to FIG. 4A
  • FIG. 5A is a side view of the injection device at the beginning of the needle retraction
  • FIG. 5B a sectional view according to FIG. 5A
  • Figure 6A a side view of the injection device after completion of the needle retraction
  • FIG. 6B a sectional view according to FIG. 6A
  • a two-chamber ampoule 111 For injection of the active ingredient, a two-chamber ampoule 111 is used.
  • Such an ampoule (FIG. 1B) has two pistons 111A, 111B, thereby forming two initially independent chambers 111C, 111D.
  • FIG. 1A shows a plan view
  • FIG. 1B shows a section in the starting position of the injection device
  • FIG. 1C shows a further section in the plane S-S.
  • All components are located in a housing 101, which consists of two trough-shaped half shells.
  • the movement components are in this case held displaceably in the injection device parallel to the longitudinal axis of the needle.
  • the components are assigned to one another as follows:
  • a two-chamber ampoule 111 is held in a receptacle 103.
  • a plug 104 at the rear end of which a control lever 105 is articulated, is held on a latching hook 102A of a spring-loaded first button 102.
  • the receptacle 103 is held on a latching hook 116A of a spring-loaded second button 116.
  • the end of a pull cable 114 which is deflected by a roller 108 mounted in a slide 109, and connected to a tension spring 110 which is fixed to the housing 101 acts.
  • the tension spring 110 thus exerts a pull on the receptacle 103 in the opposite direction to the puncture site.
  • the receptacle 103 can not move axially, since it is held by the latching hook 116 A on the second key 116.
  • the deflection of the pull cable 114 via the roller 109 creates a force on the carriage 108 in the direction of the puncture site.
  • the carriage 108 remains in its position because it rests on the plunger 104 via a driver 118, which is displaceably mounted in the carriage 108 perpendicular to the injection direction and is acted on by a driver spring 119, and the plunger 104 is held by the latching hook 102A on the first button 102.
  • the control lever 105 is associated with a first adjusting slide 107, in which a second adjusting slide 106 is slidably mounted.
  • the adjusting slider 106 is used for decoupling of the carriage 108 from the plunger 104.
  • the adjusting slide 106,107 are designed as slidably mounted stop elements for setting the plunge depth and injection volume, as will be explained below.
  • a retraction handle 117 which is connected to a pull rod 115, serves to produce this starting position.
  • the pull rod 115 is acted upon by a return spring 120.
  • the control lever 105 can pivot downwards (arrow in FIG. 4A), since it is no longer prevented by the first adjusting slide 107 because of its recessed surface.
  • the receptacle 103 remains in its position, only the plunger 104 continues to move towards the puncture site, d. H. the injection of the drug takes place, the injection stroke H2 is carried out.
  • the carriage 108 is now at the adjusting slide 106. Since the adjusting slide 106 is held in a form-fitting manner on the housing 101 via the first adjusting slide 107, the tensile force of the tension spring 110 (which is fastened to the housing 101) now acts via the roller 109 on the receptacle 103, which is thereby retracted and thus the needle from the puncture site pulls ( Figure 6A, 6B), the return stroke H3 is performed.
  • the ampoule can now be removed.
  • the injection volume and puncture depth can be set as follows:
  • the first adjusting slide 107 is axially displaceably mounted in the housing 101, he has in this example 2 locking positions (10 and 12 mm, in the example set to 10 mm). These latching positions are assigned to the plunge stroke H1, since the axial position of the adjusting slide 107 determines the path until the control lever 105 decouples the plunger 104 from the receptacle 103 (FIG. 2A).
  • the second adjusting slide 106 is likewise mounted so as to be axially displaceable with detent positions in the example 4 (1.0, 0.75, 0.5, 0.25, set to 1.0 in the example). These latching positions are associated with the injection stroke H2, since the axial position of the adjusting slide 106 determines the path until the plunger 104 is decoupled from the carriage 108 ( Figure 5A, 5B) and the needle retraction takes place.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

An injection device for holding and activating a two-chamber ampulla has components whose relative movement causes the pistons of the two-chamber ampulla to be moved in order to mix the substances, as well as devices for injecting the product which is mixed in this way. For this purpose, a receptacle (103) into which the two-chamber ampulla (111) can be inserted and secured is held in a housing (101), and the receptacle (103) can be displaced by means of a carriage (108). A tappet (104) which acts on the pistons (111A, 111B) is movably held in the receptacle (103). A traction cable (114) which is deflected by means of a roller (109) which is mounted on the carriage (108) and one of whose ends is connected to the receptacle (103) and the other end of which is connected to a tension spring (110) which is held on the housing (101) is provided in order to carry out a mixing stroke, insertion stroke, injection stroke and a return stroke. Devices which can be activated automatically and/or manually between the housing (101), receptacle (103), tappet (104) and carriage (108) control their alternating coupling to the traction cable (114) and thus the sequence of the mixing stroke, insertion stroke, injection stroke and return stroke. The invention thus provides a partially automatic injection device for two-chamber ampullas whose handling comfort and safety for the patient are substantially improved.

Description

AUTOMATISCHE INJEKTIONSVORRICHTUNG FUR ZWEI-KAMMER-AMPULLEN AUTOMATIC INJECTION DEVICE FOR TWO-CHAMBER AMPOULE
Zur Behandlung einer Vielzahl von Krankheiten, die inzwischen eine große Verbreitung haben, wie z.B. der Zuckerkrankheit, muss der Patient selbständig sich die benötigte Menge eines Wirkstoffes/Arzneimittels mittels einer Spritze oder einer Karpule injizieren. Um dies sicherer und einfacher zu gestalten, sind eine Vielzahl von Injektionsvorrichtungen bekannt, die einen weitgehend automatischen Ablauf vom Einstechen der Nadel, Injizieren des Wirkstoffes und Zurückholen der Nadel beinhalten.For the treatment of a variety of diseases that have become very widespread, such as diabetes, the patient must self-inject the required amount of an agent / drug by means of a syringe or a carpule. To make this safer and easier, a variety of injection devices are known, which include a largely automatic process of piercing the needle, injecting the drug and retrieving the needle.
Stand der TechnikState of the art
Zur Verwendung von Einwegspritzen sind mehrere Vorrichtungen zur automatischen Injektion des in der Spritze enthaltenen Wirkstoffs bekannt; so zeigen z.B. die WO 2005/011780 oder die WO 99/56805 Injektionsvorrichtungen, die bei einfacher Bedienung einen vollautomatischen Ablauf der oben beschriebenen Vorgänge ermöglichen.For use of disposable syringes, several devices are known for automatically injecting the drug contained in the syringe; e.g. WO 2005/011780 or WO 99/56805 injection devices that allow a simple operation of a fully automatic sequence of operations described above.
In jüngerer Zeit hat sich gezeigt, dass eine Verbesserung des Behandlungsergebnisses oder auch überhaupt eine Sicherung eines medizinischen Erfolges die Verwendung von Wirkstoffen erfordert, die unmittelbar vor der Injektion mit einem anderen Wirkstoff gemischt werden müssen, ein Beispiel hierfür ist Betaferon zur Mischung mit einer NaCI-Lösung. Zur Erreichung dieses Ziels sind die beiden Wirkstoffe in der Regel in einem Spritzenkörper mit zwei Kammern untergebracht, die voneinander getrennt sind und zwischen denen erst kurz vor der Injektion eine Verbindung hergestellt wird, über die dann die beiden Wirkstoffe (wenn möglich, für den Patienten sicht- bar verfolgbar) gemischt werden. Für diese speziellen Spritzenkörper, die im folgenden als Zwei-Kammer- Ampullen bezeichnet werden, sind Injektionsvorrichtungen bekannt, mit deren Hilfe eine Abfolge von Mischen, Einstechen und Injizieren ermöglicht wird (DE 600 11 853 T2). Die Steuerung dieser Abläufe erfolgt jedoch manuell und erfordert somit zur Handhabung große Aufmerksamkeit seitens des Patienten, zumal auch kein Zurückholen der Nadel nach abgeschossener Injektion vorgesehen ist.More recently, it has been found that improving the outcome of the treatment or even ensuring medical success requires the use of drugs that need to be mixed with another drug just prior to injection, an example being Betaferon for mixing with a NaCl. Solution. To achieve this goal, the two active ingredients are usually housed in a syringe body with two chambers, which are separated from each other and between which a connection is made shortly before the injection, then the two active ingredients (if possible, for the patient - Bar trackable). For these special syringe bodies, which are referred to below as two-chamber ampoules, injection devices are known, with the aid of a sequence of mixing, puncturing and injecting is made possible (DE 600 11 853 T2). However, the control of these processes is done manually and thus requires for handling great attention on the part of the patient, especially since no retrieval of the needle is provided after shot injection.
Eine Verabreichungseinrichtung für eine Mehrkammerampulle zeigt die DE 103 40 585 A1. Hier ist der manuelle Aufwand zur Injektion ähnlich, zwei zylindrische, koaxial einander zugeordnete Gehäusehälften, in denen die Ampulle eingelegt ist, werden zum Mischen manuell zusammengedrückt bzw. -geschraubt, bis eine Endposition erreicht ist; danach soll die Injektion die Injektion durch einen 'Verabreichungsmechanismus1 durchgeführt werden, der nicht näher dargestellt ist. Ein automatisiertes Zurückholen der Nadel ist auch hier nicht vorgesehen.An administration device for a multi-chamber ampoule is shown in DE 103 40 585 A1. Here, the manual effort for injection is similar, two cylindrical, coaxially associated with each other housing halves in which the ampoule is inserted, are manually pressed or mixed for mixing until an end position is reached; Thereafter, the injection is to be performed by an injection mechanism 1 , which is not shown in detail. An automated retrieval of the needle is not provided here.
Darstellung der ErfindungPresentation of the invention
Es ist Aufgabe der Erfindung, eine Injektionsvorrichtung für eine Zwei- Kammer-Ampulle durch Automatisierung der Abläufe derart weiterzubilden, dass bei einfacher mechanischer Gestaltung der Handhabungskomfort und die Sicherheit für den Patienten erhöht wird.It is an object of the invention to further develop an injection device for a two-chamber ampoule by automation of the processes such that, with a simple mechanical design, handling comfort and safety for the patient are increased.
Eine weitere Aufgabe besteht darin, die bei Zwei-Komponenten-Wirkstoffen relativ kritischen Dosierungen für den einzelnen Patienten und auch die damit verbundenen Einstechtiefen an der Einstechstelle individuell zu regeln, so dass eine Optimierung für den jeweiligen Patienten sowohl hinsichtlich des injizierten Wirkstoffvolumens, als auch hinsichtlich der Einstichtiefe der Nadel erzielt werden kann. Die erfindungsgemäße Injektionsvorrichtung löst diese Aufgabe mit den Merkmalen des Patentanspruchs 1.Another object is to individually regulate the relatively critical for two-component drugs dosages for the individual patient and the associated penetration depths at the puncture site, so that an optimization for each patient both in terms of the injected drug volume, as well as the penetration depth of the needle can be achieved. The injection device according to the invention solves this problem with the features of patent claim 1.
Der grundlegende Erfindungsgedanke ist darin zu sehen, die Aufeinanderfol- ge der Hube ausschließlich durch einen einfachen Antriebsmechanismus, einen Seilzug, zu bewirken. Hierbei wird der vom Stössel durch Beaufschlagung der Zwei-Kammer-Ampulle durchgeführte Hub in einen vorausgehenden Mischhub und einen Injektionshub unterteilt, die durch den Einstechhub unterbrochen werden. Damit ist gewährleistet, dass das Einstechen der Na- del in die Einstichstelle erst erfolgt, wenn die Mischung der beiden Wirkstoffe erfolgt ist und vom Patienten gegebenenfalls durch ein Fenster als korrekt beurteilt worden ist.The basic idea of the invention is to bring about the succession of the hoop exclusively by means of a simple drive mechanism, a cable pull. Here, the stroke performed by the plunger by acting on the two-chamber ampoule is divided into a preliminary mixing stroke and an injection stroke, which are interrupted by the Einstechhub. This ensures that the needle is not pierced into the puncture site until the two active ingredients have been mixed and, if appropriate, assessed by the patient through a window as correct.
Bevorzugte Ausgestaltung betreffen die Auslegung der Einstellelemente zur Ablaufsteuerung, die auch zur voneinander unabhängigen Einstellung der Einstechtiefe und der Einstellung des Injektionsvolumens des gemischten Wirkstoffes ausgebildet sind.Preferred embodiments relate to the design of the setting elements for sequence control, which are also designed for independent adjustment of the piercing depth and the adjustment of the injection volume of the mixed active substance.
Weitere konstruktive Ausgestaltungen sind weiteren Unteransprüchen zu entnehmen.Further constructive embodiments can be found in further subclaims.
Kurze Beschreibung der ZeichnungenBrief description of the drawings
Ein bevorzugtes Ausführungsbeispiel der Injektionsvorrichtung wird nun an- hand von Zeichnungen näher erläutert. Es zeigen:A preferred embodiment of the injection device will now be explained in more detail with reference to drawings. Show it:
Figur 1 A: Eine Seitenansicht der Injektionsvorrichtung in Ausgangsstellung,FIG. 1A: a side view of the injection device in the starting position,
Figur 1 B: einen Schnitt durch die Injektionsvorrichtung der Figur 1 in ihrer Grundstellung in ihrer Mittelebene,1 B: a section through the injection device of Figure 1 in its normal position in its center plane,
Figur 1C: einen Schnitt durch die Injektionsvorrichtung in der Ebene S-S der Figur 1 B, Figur 2A: eine Seitenansicht der Injektionsvorrichtung bei der Durchführung des Mischhubes,FIG. 1C shows a section through the injection device in the plane SS of FIG. 1B, FIG. FIG. 2A shows a side view of the injection device during the execution of the mixing stroke,
Figur 2B: eine Schnittdarstellung entsprechend Figur 2A,FIG. 2B: a sectional view corresponding to FIG. 2A,
Figur 3A: eine Seitenansicht der Injektionsvorrichtung beim Einstechhub,FIG. 3A shows a side view of the injection device during the insertion stroke,
Figur 3B: eine Schnittdarstellung gemäß Figur 3A,FIG. 3B: a sectional view according to FIG. 3A,
Figur 4A: eine Seitendarstellung der Injektionsvorrichtung bei Injektionshub,FIG. 4A: a side view of the injection device during the injection stroke,
Figur 4B: eine Schnittdarstellung gemäß Figur 4A,FIG. 4B: a sectional view according to FIG. 4A,
Figur 5A: eine Seitendarstellung der Injektionsvorrichtung zu Beginn des Nadelrückzugs,FIG. 5A is a side view of the injection device at the beginning of the needle retraction;
Figur 5B: eine Schnittdarstellung gemäß Figur 5A,FIG. 5B: a sectional view according to FIG. 5A,
Figur 6A: eine Seitenansicht der Injektionsvorrichtung nach Beendigung des Nadelrückzugs, undFigure 6A: a side view of the injection device after completion of the needle retraction, and
Figur 6B: eine Schnittdarstellung gemäß Figur 6A,FIG. 6B: a sectional view according to FIG. 6A,
Beschreibung des AusführunαsbeispielsDescription of the Ausführunαsbeispiels
Zur Injektion des Wirkstoffes wird eine Zweikammer-Ampulle 111 verwendet. Eine solche Ampulle (Figur 1 B) hat zwei Kolben 111A, 111 B, dadurch erge- ben sich zwei zunächst voneinander unabhängige Kammern 111 C, 111 D. In die erste, innere Kammer 111C, die der Kanüle 112 zugewandt ist, wird zum Beispiel Betaferon in Pulverform, in die zweite, äussere Kammer 111 D eine NaCI - Lösung eingefüllt.For injection of the active ingredient, a two-chamber ampoule 111 is used. Such an ampoule (FIG. 1B) has two pistons 111A, 111B, thereby forming two initially independent chambers 111C, 111D. Into the first, inner chamber 111C, which faces the cannula 112, becomes, for example Betaferon in powder form, filled in the second, outer chamber 111 D a NaCl solution.
Wird nun ein Stössel 104 gegen den äußeren Kolben 111 B gedrückt, verschiebt sich zunächst auch der innere Kolben 111A, da die NaCI - Lösung die Kraft des Stössels hydraulisch auf den inneren Kolben 111A überträgt. Sobald der innere Kolben 111A einen Überströmkanal 111 E in Form einer nutförmigen Ausbuchtung im Mantel der Ampulle 111 überlaufen hat, bleibt dieser stehen und die NaCI- Lösung strömt über diesen Überströmkanal 111 E in die innere Kammer 111C und mischt sich mit dem Betaferon. Nach dem Mischen erfolgt dann (nach dem Einstechhub) die Injektion durch das Weiterbewegen des Stössels 104.If now a plunger 104 is pressed against the outer piston 111 B, initially also the inner piston 111A shifts, since the NaCl solution hydraulically transfers the force of the plunger to the inner piston 111A. As soon as the inner piston 111A has overflowed an overflow channel 111 E in the form of a groove-shaped bulge in the shell of the ampoule 111, it stops and the NaCl solution flows via this overflow channel 111 E into the inner chamber 111 C and mixes with the Betaferon. To the mixing then takes place (after the plunge stroke) the injection by the further movement of the plunger 104.
Figur 1A zeigt eine Aufsicht, Figur 1 B einen Schnitt in der Ausgangsstellung der Injektionsvorrichtung, Figur 1C einen weiteren Schnitt in der Ebene S-S.FIG. 1A shows a plan view, FIG. 1B shows a section in the starting position of the injection device, FIG. 1C shows a further section in the plane S-S.
Sämtliche Bauteile befinden sich in einem Gehäuse 101 , das aus zwei wan- nenförmigen Halbschalen besteht. Die Bewegungsbauteile sind hierbei in der Injektionsvorrichtung parallel zur Längsachse der Nadel verschiebbar gehal- ten. Die Bauteile sind wie folgt einander zugeordnet:All components are located in a housing 101, which consists of two trough-shaped half shells. The movement components are in this case held displaceably in the injection device parallel to the longitudinal axis of the needle. The components are assigned to one another as follows:
Eine Zweikammer-Ampulle 111 ist in einer Aufnahme 103 gehalten. Ein Stö- ssel 104, an dessen hinterem Ende ein Steuerhebel 105 angelenkt ist, ist an einem Rasthaken 102A einer federbeaufschlagten ersten Taste 102 gehal- ten. Die Aufnahme 103 ist an einem Rasthaken 116A einer federbeaufschlagten zweiten Taste 116 gehalten.A two-chamber ampoule 111 is held in a receptacle 103. A plug 104, at the rear end of which a control lever 105 is articulated, is held on a latching hook 102A of a spring-loaded first button 102. The receptacle 103 is held on a latching hook 116A of a spring-loaded second button 116.
Auf die Aufnahme 103 wirkt das Ende eines Zugseils 114, welches über eine in einem Schlitten 108 gelagerte Rolle 109 umgelenkt wird, und mit einer Zugfeder 110 verbunden ist, die am Gehäuse 101 befestigt ist. Die Zugfeder 110 übt somit einen Zug auf die Aufnahme 103 in entgegengesetzter Richtung zur Einstichstelle aus. Die Aufnahme 103 kann sich jedoch nicht axial verschieben, da sie vom Rasthaken 116A an der zweiten Taste 116 gehalten wird.On the receptacle 103, the end of a pull cable 114, which is deflected by a roller 108 mounted in a slide 109, and connected to a tension spring 110 which is fixed to the housing 101 acts. The tension spring 110 thus exerts a pull on the receptacle 103 in the opposite direction to the puncture site. However, the receptacle 103 can not move axially, since it is held by the latching hook 116 A on the second key 116.
Durch die Umlenkung des Zugseiles 114 über die Rolle 109 entsteht eine Kraft auf den Schlitten 108 in Richtung der Einstichstelle. Der Schlitten 108 bleibt jedoch in seiner Position, da er über einen im Schlitten 108 senkrecht zur Injektionsrichtung verschiebbar gelagerten von einer Mitnehmerfeder 119 beaufschlagten Mitnehmer 118 am Stössel 104 anliegt und der Stössel 104 vom Rasthaken 102A an der ersten Taste 102 gehalten wird. Dem Steuerhebel 105 ist ein erster Einstellschieber 107 zugeordnet, in dem ein zweiter Einstellschieber 106 verschiebbar gelagert ist. Der Einstellschieber 106 dient zur Entkoppelung des Schlittens 108 vom Stössel 104. Die Einstellschieber 106,107 sind als verschiebbar gelagerte Anschlagelemente zur Einstellung von Einstechtiefe und Injektionsvolumen ausgebildet, wie dies weiter unten noch erläutert wird.The deflection of the pull cable 114 via the roller 109 creates a force on the carriage 108 in the direction of the puncture site. The carriage 108, however, remains in its position because it rests on the plunger 104 via a driver 118, which is displaceably mounted in the carriage 108 perpendicular to the injection direction and is acted on by a driver spring 119, and the plunger 104 is held by the latching hook 102A on the first button 102. The control lever 105 is associated with a first adjusting slide 107, in which a second adjusting slide 106 is slidably mounted. The adjusting slider 106 is used for decoupling of the carriage 108 from the plunger 104. The adjusting slide 106,107 are designed as slidably mounted stop elements for setting the plunge depth and injection volume, as will be explained below.
Ein Rückzuggriff 117, der mit einer Zugstange 115 verbunden ist, dient zur Herstellung dieser Ausgangslage. Die Zugstange 115 wird durch eine Rück- zugfeder 120 beaufschlagt.A retraction handle 117, which is connected to a pull rod 115, serves to produce this starting position. The pull rod 115 is acted upon by a return spring 120.
Beschreibung des AblaufesDescription of the process
Wird die erste Taste 102 betätigt, kommt der Rasthaken 102A außer Eingriff, der Stössel 104 wird freigegeben und bewegt sich in Richtung Einstichstelle, bis die Vorderkante des Steuerhebels 105 an der Aufnahme 103 anliegt. Auf diese Weise wird der äußere Kolben 111B der Ampulle 111 beaufschlagt, bewegt sich nach vorne und führt einen Mischhub HO durch. Dieser Mischhub dient dem Mischen der NaCI-Lösung mit dem Betaferon wie oben be- schrieben (Figur 2A, Figur 2B). Durch ein Sichtfenster im Gehäuse 101 kann die Vermischung des Betaferons mit der NaCI-Lösung kontrolliert werden.When the first button 102 is actuated, the latching hook 102A comes out of engagement, the plunger 104 is released and moves in the direction of puncture until the front edge of the control lever 105 is applied to the receptacle 103. In this way, the outer piston 111B of the ampoule 111 is charged, moves forward, and performs a mixing stroke HO. This mixing stroke serves to mix the NaCl solution with the Betaferon as described above (FIG. 2A, FIG. 2B). Through a viewing window in the housing 101, the mixing of the Betaferon with the NaCl solution can be controlled.
Da das freie Ende des Steuerhebels 105 andererseits auf dem zweiten Einstellschieber 107 gleitet und dort aufliegt, kann er an dieser Stelle nicht durch Verschwenken nach unten ausweichen; somit wird die Zugkraft der Zugfeder 110 in Richtung Einstichstelle vom Schlitten 108 über den Stössel 104 auf die Aufnahme 103 übertragen. Die Aufnahme 103 bleibt jedoch in ihrer Lage, da sie vom Rasthaken 116A der Taste 116 arretiert ist.On the other hand, since the free end of the control lever 105 slides on the second adjusting slide 107 and rests there, it can not escape at this point by pivoting down; Thus, the tensile force of the tension spring 110 is transmitted in the direction of puncture site of the carriage 108 via the plunger 104 on the receptacle 103. However, the receptacle 103 remains in its position because it is locked by the latching hook 116 A of the key 116.
Wird nun die zweite Taste 116 betätigt, kommt der Rasthaken 116A außer Eingriff und die Aufnahme 103 wird freigegeben; dadurch bewegen sich der Stössel 104 und die Aufnahme 103 unter der Wirkung der Zugfeder 110 ge- - T -If now the second button 116 is actuated, the latching hook 116A is disengaged and the receptacle 103 is released; As a result, the plunger 104 and the receptacle 103 move under the action of the tension spring 110. - T -
meinsam in Richtung Einstichstelle. Die Nadel wird eingestochen (Figur 3A.3B), der Einstechhub H1 wird durchgeführt (Figur 4A, 4B)in the direction of the puncture site. The needle is inserted (Figure 3A.3B), the insertion stroke H1 is performed (Figure 4A, 4B)
Ist die gewünschte Einstechtiefe erreicht, kann der Steuerhebel 105 nach unten schwenken (Pfeil in Figur 4A), da er nicht mehr durch den ersten Einstellschieber 107 wegen dessen zurückspringender Oberfläche daran gehindert wird. Es erfolgt somit keine Kraftübertragung mehr vom Stössel 104 auf die Aufnahme 103, die Aufnahme 103 verbleibt in ihrer Position, nur der Stössel 104 bewegt sich weiter zur Einstichstelle hin, d. h. die Injektion des Arz- neimittels erfolgt, der Injektionshub H2 wird durchgeführt.Once the desired plunge depth has been reached, the control lever 105 can pivot downwards (arrow in FIG. 4A), since it is no longer prevented by the first adjusting slide 107 because of its recessed surface. Thus, there is no more power transmission from the plunger 104 to the receptacle 103, the receptacle 103 remains in its position, only the plunger 104 continues to move towards the puncture site, d. H. the injection of the drug takes place, the injection stroke H2 is carried out.
Erreicht der im Schlitten 108 verschiebbar gelagerte Mitnehmer 118 die Rampe 106A des zweiten Einstellschiebers 106 (Figur 4B), wird der Mitnehmer 118 nach unten gezogen und somit der Schlitten 108 vom Stössel 104 entkoppelt, d. h. zu diesem Zeitpunkt wird die Injektion beendet (Figur 5B).If the driver 118 displaceably mounted in the carriage 108 reaches the ramp 106A of the second adjusting slide 106 (FIG. 4B), the driver 118 is pulled downwards and thus the carriage 108 is decoupled from the tappet 104, ie. H. at this point the injection is terminated (Figure 5B).
Der Schlitten 108 steht nun am Einstellschieber 106 an. Da der Einstellschieber 106 über den ersten Einstellschieber 107 formschlüssig am Gehäuse 101 gehalten wird, wirkt nun die Zugkraft der Zugfeder 110 (die am Ge- häuse 101 befestigt ist) über die Rolle 109 auf die Aufnahme 103, die dadurch zurückgezogen wird und damit die Nadel aus der Einstichstelle zieht (Figur 6A, 6B), der Rückholhub H3 wird durchgeführt.The carriage 108 is now at the adjusting slide 106. Since the adjusting slide 106 is held in a form-fitting manner on the housing 101 via the first adjusting slide 107, the tensile force of the tension spring 110 (which is fastened to the housing 101) now acts via the roller 109 on the receptacle 103, which is thereby retracted and thus the needle from the puncture site pulls (Figure 6A, 6B), the return stroke H3 is performed.
Durch Herunterklappen des Rückzuggriffes 117, der mit der Zugstange 115 verbunden ist, und Herausziehen der Zugstange 115 werden der Schlitten 108 und alle anderen Elemente wieder in ihre Ausgangslage (Figur 1A,1B) zurückgezogen. Die Zugstange 115 wird durch die Rückzugfeder 120 wieder eingezogen.By folding down the retracting handle 117, which is connected to the pull rod 115, and pulling out the pull rod 115, the carriage 108 and all other elements are pulled back into their initial position (Figure 1A, 1B). The pull rod 115 is retracted by the return spring 120 again.
Die Ampulle kann nun entnommen werden.The ampoule can now be removed.
Das Injektionsvolumen und die Einstechtiefe lassen sich wie folgt einstellen: Der erste Einstellschieber 107 ist im Gehäuse 101 axial verschiebbar gelagert, er hat in diesem Beispiel 2 Rastpositionen (10 und 12 mm, im Beispiel auf 10 mm eingestellt). Diese Rastpositionen sind dem Einstechhub H1 zu- geordnet, da die axiale Lage des Einstellschiebers 107 den Weg bestimmt, bis der Steuerhebel 105 den Stössel 104 von der Aufnahme 103 entkoppelt (Figur 2A).The injection volume and puncture depth can be set as follows: The first adjusting slide 107 is axially displaceably mounted in the housing 101, he has in this example 2 locking positions (10 and 12 mm, in the example set to 10 mm). These latching positions are assigned to the plunge stroke H1, since the axial position of the adjusting slide 107 determines the path until the control lever 105 decouples the plunger 104 from the receptacle 103 (FIG. 2A).
Im ersten Einstellschieber 107 ist der zweite Einstellschieber 106 ebenfalls axial verschiebbar mit im Beispiel 4 Rastpositionen gelagert (1.0; 0,75; 0,5; 0,25, im Beispiel auf 1 ,0 eingestellt). Diese Rastpositionen sind dem Injektionshub H2 zugeordnet, da die axiale Lage des Einstellschiebers 106 den Weg bestimmt, bis der Stössel 104 vom Schlitten 108 entkoppelt wird (Figur 5A,5B) und der Nadelrückzug erfolgt.In the first adjusting slide 107, the second adjusting slide 106 is likewise mounted so as to be axially displaceable with detent positions in the example 4 (1.0, 0.75, 0.5, 0.25, set to 1.0 in the example). These latching positions are associated with the injection stroke H2, since the axial position of the adjusting slide 106 determines the path until the plunger 104 is decoupled from the carriage 108 (Figure 5A, 5B) and the needle retraction takes place.
Soll nun z. B. eine Einstechtiefe von 12 mm eingestellt werden, muss gegenüber dem dargestellten Zustand der erste Einstellschieber 107 um 2 mm in Richtung der Einstechstelle in die neue Rastposition am Gehäuse 101 verschoben werden. Da der zweite Einstellschieber 106 mit dem ersten Einstell- Schieber 107 in der Position 1 ,0 verrastet ist, verschiebt sich auch dieser um 2 mm zur Einstechstelle hin, d. h., die Einstellung einer anderen Einstechtiefe wirkt sich nicht auf die Einstellung des Injektionsvolumens aus. Ebenso wirkt sich die Einstellung des Injektionsvolumens nicht auf Einstechtiefe aus; die Einstellungen von Einstechhub H1 und Injektionshub H2 sind unabhängig voneinander. BezuαszeichenShould now z. B. a puncture depth of 12 mm are set, relative to the illustrated state of the first adjusting slide 107 must be moved by 2 mm in the direction of the puncture in the new detent position on the housing 101. Since the second adjusting slider 106 is locked in position 1, 0 with the first adjusting slide 107, this also shifts by 2 mm towards the piercing point, ie the setting of another piercing depth does not affect the setting of the injection volume. Likewise, the setting of the injection volume does not affect puncture depth; the settings of plunge stroke H1 and injection stroke H2 are independent of each other. Bezuαszeichen
Gehäuse 101 erste Taste 102Housing 101 first button 102nd
Rasthaken 102ALatch hook 102A
Aufnahme 103Recording 103
Stössel 104Pestle 104
Steuerhebel 105 erster Einstellschieber 107 zweiter Einstellschieber 106Control lever 105 first adjusting slide 107 second adjusting slide 106th
Rampe 106ARamp 106A
Schlitten 108Carriage 108
Rolle 109 Feder 110Roller 109 spring 110
Ampulle 111Ampoule 111
Kanüle 112Cannula 112
Zugseil 114Pulling cable 114
Zugstange 115 zweite Taste 116Pull rod 115 second button 116
Rasthaken 116ALatching hook 116A
Rückzuggriff 117Retreat handle 117
Mitnehmer 118Driver 118
Mitnehmerfeder 119 Rückzugfeder 120 Driving spring 119 Retracting spring 120

Claims

Patentansprüche claims
1. Injektionsvorrichtung zur Aufnahme und Betätigung einer Zwei-Kammer- Ampulle, mit einer Injektionsnadel und mit Bauteilen, durch deren Relativbewegung die Kolben der Zwei-Kammer-Ampulle (111) zur Mischung der Substanzen verschoben werden, bis der innere Kolben (111A) den Überströmkanal (111 E) der Zwei-Kammer-Ampulle erreicht und stehen bleibt, worauf der äußere Kolben (111 B) den in der hinteren Kammer (111 D) be- findlichen ersten Wirkstoff in die zur Injektionsnadel führende vordere Kammer (111C) mit dem zweiten Wirkstoff fördert, sowie mit Vorrichtungen zur Injektion des derart gemischten Produkts, dadurch gekennzeichnet, dass in einem Gehäuse (101) eine Aufnahme (103) gehalten ist, in die die Zwei-Kammer-Ampulle (111) einlegbar und fixierbar ist, dass die Aufnahme (103) mittels eines Schlittens (108) verschiebbar ist, dass in der Aufnahme (103) ein Stössel (104) verschiebbar gehalten ist, der die Kolben (111A,111 B) beaufschlagt, und dass zur Durchführung von Mischhub, Einstechhub, Injektionshub und eines Rückholhubes ein Zugseil (114) vorgesehen ist, das über eine am Schlitten (108) gelagerte Rolle (109) umgelenkt wird, und dessen eines Ende mit der Aufnahme (103) und dessen anderes Ende mit einer Zugfeder (110) verbunden ist, die am Gehäuse (101) gehalten ist, wobei automatisch und/oder manuell betätigbare Einrichtungen zwischen Gehäuse (101), Aufnahme (103), Stössel (104) und Schlitten (108) deren wechselseitige Kopplung mit dem Zugseil (114) und damit die Abfolge von Mischhub, Einstechhub, Injektionshub und Rückholhub steuern.1. Injection device for receiving and actuating a two-chamber ampoule, with an injection needle and with components, by the relative movement of the pistons of the two-chamber ampoule (111) are moved to mix the substances until the inner piston (111 A) Passage channel (111 E) of the two-chamber ampoule reaches and stops, whereupon the outer piston (111 B) in the rear chamber (111 D) the first active ingredient in the leading to the injection needle front chamber (111 C) with the promotes second active ingredient, as well as with devices for injection of the product thus mixed, characterized in that in a housing (101) a receptacle (103) is held, in which the two-chamber ampule (111) can be inserted and fixed, that the Recording (103) by means of a carriage (108) is displaceable, that in the receptacle (103) a plunger (104) is slidably supported, which acts on the pistons (111A, 111 B), and that for performing Mischhub , Einstechhub, injection stroke and a Rückholhubes a pull rope (114) is provided, which is deflected by a roller (109) mounted on the carriage (108) and having one end with the receptacle (103) and the other end with a tension spring (110 ), which is held on the housing (101), wherein automatically and / or manually operable means between housing (101), receptacle (103), ram (104) and carriage (108) whose mutual coupling with the pull cable (114) and thus control the sequence of mixing stroke, plunge stroke, injection stroke and return stroke.
2. Injektionsvorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass erste Einrichtungen zur lösbaren Arretierung des Stössels (104) zur Ein- leitung des Mischhubs vorgesehen sind. 2. Injection device according to claim 1, characterized in that first means are provided for releasably locking the plunger (104) for introducing the mixing stroke.
3. Injektionsvorrichtung nach Anspruch 2, dadurch gekennzeichnet, dass die ersten Einrichtungen aus einem Rasthaken (102A) einer federbeaufschlagten, ersten Taste (102) am Gehäuse (101) bestehen, der am Stö- ssel (104) angreift.3. Injection device according to claim 2, characterized in that the first means consist of a latching hook (102A) of a spring-loaded, first button (102) on the housing (101), which engages on the peg (104).
4. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass zweite Einrichtungen zur lösbaren Arretierung der Aufnahme (103) zur Einleitung des Einstechhubs nach dem Mischhub vorgesehen sind.4. Injection device according to claim 1, characterized in that second means for releasably locking the receptacle (103) are provided for initiating the Einstechhubs after the mixing stroke.
5. Injektionsvorrichtung nach Anspruch 4, dadurch gekennzeichnet, dass die zweiten Einrichtungen aus einem Rasthaken (116A) an mindestens einer federbeaufschlagten Taste (116) am Gehäuse (101) bestehen, der an der Aufnahme (103) angreift.5. Injection device according to claim 4, characterized in that the second means consist of a latching hook (116A) on at least one spring-loaded button (116) on the housing (101), which acts on the receptacle (103).
6. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass das Zugseil (114) über den Schlitten (108) und die Rolle (109) bei dem auf den Injektionshub folgenden Rückholhub die Aufnahme (103) mit der Ampulle und der Injektionsnadel aus der Einstichstelle zieht.6. Injection device according to claim 1, characterized in that the pull cable (114) pulls the receptacle (103) with the ampoule and the injection needle out of the puncture site via the carriage (108) and the roller (109) during the return stroke following the injection stroke ,
7. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass dritte Einrichtungen zur Koppelung des Stössels (104) mit der Aufnahme (103) vorgesehen sind, die den Stössel (104) zur Durchführung des Einstechhubs mit der Aufnahme (103) koppeln und zur Durchführung des Injektionshubs entkoppeln.7. Injection device according to claim 1, characterized in that third means for coupling the plunger (104) with the receptacle (103) are provided, which couple the plunger (104) for performing the Einstechhubs with the receptacle (103) and for carrying out the Decouple injection hubs.
8. Injektionsvorrichtung nach Anspruch 8, dadurch gekennzeichnet, dass die dritten Einrichtungen aus einem Steuerhebel (105) bestehen, dessen eines Ende am Stössel (104) angelenkt ist und dessen anderes Ende die Aufnahme (103) beaufschlagt.8. Injection device according to claim 8, characterized in that the third means consist of a control lever (105) whose one end is articulated on the plunger (104) and whose other end acts on the receptacle (103).
9. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass vierte Einrichtungen zur Koppelung von Schlitten (108) und Stössel (104) vorgesehen sind, die Schlitten (108) und Stössel (104) vom Beginn des Mischhubes bis zum Ende des Injektionshubs koppeln.9. Injection device according to claim 1, characterized in that fourth means for coupling slide (108) and plunger (104) are provided, the carriage (108) and plunger (104) from the beginning of the mixing stroke to the end of the injection stroke couple.
10. Injektionsvorrichtung nach Anspruch 9, dadurch gekennzeichnet, dass die vierten Einrichtungen aus einem federbeaufschlagten Mitnehmer (118) bestehen, der im Schlitten (108) gelagert ist und in seiner Koppelposition am Stössel (104) angreift.10. Injection device according to claim 9, characterized in that the fourth means consist of a spring-loaded driver (118) which is mounted in the carriage (108) and engages in its coupling position on the plunger (104).
11. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass sie einen ersten Einstellschieber (107) enthält, der eine Einstellung des Wegs des Einstechhubs und damit der Einstechtiefe bewirkt.11. Injection device according to claim 1, characterized in that it contains a first adjusting slide (107), which causes an adjustment of the path of Einstechhubs and thus the puncture depth.
12. Injektionsvorrichtung nach Anspruch 8 und 11 , dadurch gekennzeichnet, dass der erste Einstellschieber (107) als zwischen zwei Endpositionen beliebig verschiebbar gelagertes Anschlagelement ausgebildet ist, dessen Position über den Steuerhebel (105) den Weg der Aufnahme (103) und damit die Länge des Einstechhubs bestimmt.12. Injection device according to claim 8 and 11, characterized in that the first adjusting slide (107) is formed as between two end positions arbitrarily slidably mounted stop member whose position on the control lever (105) the way of recording (103) and thus the length of the Einstechhubs determined.
13. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass sie einem zweiten Einstellschieber (106) enthält, der durch den Weg des13. Injection device according to claim 1, characterized in that it contains a second adjusting slide (106), by the way of the
Stössels (104) eine Einstellung der Länge des Injektionshubs und damit der Injektionsmenge des gemischten Wirkstoffes bewirkt.Stößels (104) causes an adjustment of the length of the injection stroke and thus the injection quantity of the mixed active substance.
14. Injektionsvorrichtung nach Anspruch 12, dadurch gekennzeichnet, dass der zweite Einstellschieber (106) als ein zwischen mindestens zwei Positionen relativ zum ersten Einstellschieber (107) verschiebbar gelagertes Anschlagelement für die Aufnahme (103) ausgebildet ist.14. Injection device according to claim 12, characterized in that the second adjusting slide (106) as a between at least two positions relative to the first adjusting slide (107) displaceably mounted stop member for receiving (103) is formed.
15. Injektionsvorrichtung nach den Ansprüchen 11 bis 14, dadurch gekenn- zeichnet, dass einer der Einstellschieber verschiebbar oder drehbar, mittelbar oder unmittelbar, im jeweils anderen Einstellschieber gelagert ist, so dass Einstechtiefe und Injektionsvolumen unabhängig voneinander einstellbar sind.15. Injection device according to claims 11 to 14, characterized in that one of the adjusting slide displaceably or rotatably, indirectly or directly, mounted in the respective other adjusting slide is, so that piercing depth and injection volume can be adjusted independently.
16. Injektionsvorrichtung nach Anspruch 1 , dadurch gekennzeichnet, dass das Gehäuse (101) aus zwei Halbschalen besteht.16. Injection device according to claim 1, characterized in that the housing (101) consists of two half-shells.
17. Injektionsvorrichtung nach Anspruch 16, dadurch gekennzeichnet, dass zumindest eine der Halbschalen ein Sichtfenster zur Kontrolle der Mischung der beiden Substanzen in der vorderen Kammer beim Mischhub aufweist. 17. Injection device according to claim 16, characterized in that at least one of the half-shells has a viewing window for controlling the mixing of the two substances in the front chamber during the mixing stroke.
PCT/DE2006/001512 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampullas WO2007033638A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
US12/067,766 US7678072B2 (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampoules
CN2006800342676A CN101267856B (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampullas
JP2008531522A JP5076109B2 (en) 2005-09-22 2006-08-31 Two-chamber ampule automatic injection device
DE112006003252T DE112006003252A5 (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampoules
CA2623152A CA2623152C (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampoules
EP06791326.9A EP1931405B1 (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampullas
BRPI0616307-6A BRPI0616307B1 (en) 2005-09-22 2006-08-31 INJECTION DEVICE TO HOLD AND ACTIVATE A TWO CAMERA LAMP
MX2008002782A MX2008002782A (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampullas.
KR1020087006734A KR101309718B1 (en) 2005-09-22 2006-08-31 Automatic injection device for two-chamber ampullas
HK08113242.1A HK1119098A1 (en) 2005-09-22 2008-12-04 Automatic injection device for two-chamber ampullas

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202005014958U DE202005014958U1 (en) 2005-09-22 2005-09-22 Injection unit comprising a seat for a syringe body with two pistons and two chambers and a means for driving the plunger to produce a mixing stroke before an injection stroke
DE202005014958.6 2005-09-22

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WO2007033638A1 true WO2007033638A1 (en) 2007-03-29

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US (1) US7678072B2 (en)
EP (1) EP1931405B1 (en)
JP (1) JP5076109B2 (en)
KR (1) KR101309718B1 (en)
CN (1) CN101267856B (en)
BR (1) BRPI0616307B1 (en)
CA (1) CA2623152C (en)
DE (2) DE202005014958U1 (en)
HK (1) HK1119098A1 (en)
MX (1) MX2008002782A (en)
TR (1) TR201901372T4 (en)
WO (1) WO2007033638A1 (en)

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KR101309718B1 (en) 2013-09-17
BRPI0616307A2 (en) 2011-06-14
CN101267856B (en) 2011-04-06
MX2008002782A (en) 2008-09-15
TR201901372T4 (en) 2019-02-21
DE112006003252A5 (en) 2008-09-04
CA2623152C (en) 2015-03-17
EP1931405B1 (en) 2018-11-14
US7678072B2 (en) 2010-03-16
HK1119098A1 (en) 2009-02-27
JP5076109B2 (en) 2012-11-21
EP1931405A1 (en) 2008-06-18
KR20080065592A (en) 2008-07-14
BRPI0616307B1 (en) 2018-06-26
US20080188798A1 (en) 2008-08-07
DE202005014958U1 (en) 2005-12-08
CN101267856A (en) 2008-09-17
CA2623152A1 (en) 2007-03-29
JP2009508602A (en) 2009-03-05

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